Cleo Diagnostics Starts Manufacturing Program with Bio-Techne Ahead of FDA Submission

Manufacturing Program Launches to Support Test Kit Production

Cleo Diagnostics (ASX:COV) has officially commenced a staged manufacturing and development program with Bio-Techne Corporation (NASDAQ: TECH), marking a pivotal shift from clinical trial sample collection to the production phase of its ovarian cancer test kits. This collaboration aims to underpin the analytical validation (AV) and clinical sample testing that are critical precursors to the company’s planned FDA 510(k) submission.

The move follows Cleo’s recent milestone of completing sample collection for its pivotal U.S. clinical trial across 19 sites, a campaign that recruited 624 women and gathered over 500 blood samples, surpassing initial targets trial sample collection milestone. With clinical data in hand, Cleo is now focusing on manufacturing readiness and assay development to ensure the test kits meet stringent regulatory standards.

Leveraging Bio-Techne’s Ella™ Platform for Assay Consistency

The staged manufacturing approach builds on Cleo’s established collaboration with Bio-Techne, utilising the Ella™ platform as the dedicated instrument for delivering its Pre-Surgical Ovarian Cancer Test. The platform’s high sensitivity, precision, and reproducibility have been confirmed in-house, providing a robust foundation for scaling production.

Initial activities are centred on developing and optimising critical assay components, including antibody production for selected biomarkers from Cleo’s proprietary panel. This modular approach is designed to reduce technical and manufacturing risk ahead of full-scale kit production, ensuring assay consistency and reproducibility are maintained throughout the process. The collaboration echoes Cleo’s earlier decision to expand its biomarker panel to eight markers to improve test robustness and scalability biomarker panel expansion.

Pathway to FDA 510(k) Submission and Clinical Sample Testing

Analytical validation is a critical regulatory requirement that will demonstrate the test kits’ reliable and reproducible performance before clinical sample analysis. Cleo’s staged manufacturing program aims to generate multiple production batches of test kits for AV, followed by testing of the clinical samples collected during the pivotal trial. The data from these activities will form the core evidence package for the FDA 510(k) submission.

Chief Executive Officer Richard Allman emphasised the importance of this phase: “Commencing our manufacturing program with Bio-Techne is an important milestone as we transition from clinical sample collection into AV and sample testing. The staged approach allows us to optimise critical assay components and reduce technical and manufacturing risk ahead of full-scale kit production.”

Bio-Techne’s global expertise in immunoassay development and commercial-scale manufacturing is expected to be instrumental in delivering the project, supporting Cleo’s final execution phase of its U.S. clinical and regulatory program.

Next Steps Focused on Validation and Regulatory Milestones

Cleo is now advancing the final development and validation activities required to generate the clinical dataset supporting FDA submission. This includes completing reagent and antibody production, manufacturing test kit batches for AV, completing the AV process itself, testing clinical trial samples with the validated test configuration, and analysing clinical data to compile the FDA evidence package.

This manufacturing program launch follows Cleo’s earlier selection of Bio-Techne’s Ella™ platform to enhance assay speed and sensitivity, a move that set the stage for streamlined FDA approval efforts Ella platform selection. As Cleo nears the final execution phase of its U.S. clinical and regulatory program, the market will be watching closely for the analytical validation results and subsequent regulatory filings.